IMPLANTABLE LAYERS FOR A SURGICAL INSTRUMENT

• US 20170049447A1
• Filed: 08/17/2015
• Published: 02/23/2017
• Est. Priority Date: 08/17/2015
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery LLC (Johnson & Johnson)
• Inventors: Barton, Trevor J., Vendely, Michael J., Aronhalt, Taylor W., Schellin, Emily A., Weaner, Lauren S.
• Granted Patent: US 10,617,418 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/105 Wound clamp magazines for packaging sharps A61B50/3001
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00884 enhancing wound closure
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00938 hydrophobic
• CPC Class Codes: A61B 2017/00942 hydrophilic
• CPC Class Codes: A61B 2017/00964 composite
• CPC Class Codes: A61B 2017/07271 characterised by its cartridge
• CPC Class Codes: A61B 2090/0816 for preventing adhesion
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: B29C 35/16 Cooling cooling extruded material B29C48/911; cooling preforms for blow moulding B29C49/6427; cooling blown articles B29C49/66; cooling tyres during post cure inflation B29D30/0643
• CPC Class Codes: B29C 44/3415 Heating or cooling
• CPC Class Codes: B29C 44/5627 by mechanical deformation, e.g. crushing, embossing, stretching
• CPC Class Codes: B29C 70/70 : Completely encapsulating inserts B29C70/86 takes precedence
• CPC Class Codes: B29K 2105/04 : cellular or porous
• CPC Class Codes: B29L 2031/7546 : Surgical equipment

Abstract

A staple cartridge is disclosed. The staple cartridge can include a cartridge body, a plurality of staples, and an implantable layer including a plurality of foam fragments, wherein the foam fragments are fused together to form a unitary body. The implantable layer can further include a plurality of intrastitial voids intermediate the foam fragments and/or a plurality of interstitial voids within the foam fragments. A method of forming an implantable layer for use with a surgical stapler is also disclosed. The method can include the steps of obtaining a plurality of foam fragments, heating the foam fragments, and compressing the foam fragments. A method of forming an implantable layer for use with a surgical stapler can also include lyophilizing a solution.

Claims

1. A staple cartridge, comprising:

a cartridge body comprising a plurality of staple cavities;

a plurality of staples removably positioned in said staple cavities; and

an implantable layer comprising a plurality of foam fragments, wherein each said foam fragment is fused to at least one other said foam fragment to form a unitary body.

2. The staple cartridge of claim 1, wherein said implantable layer further comprises:

a plurality of intrastitial voids intermediate said foam fragments; and

a plurality of interstitial voids within said foam fragments.

3. The staple cartridge of claim 1, wherein said foam fragments are randomly oriented throughout said implantable layer.

4. The staple cartridge of claim 1, wherein said plurality of foam fragments comprises:

a first foam fragment comprising a first porosity; and

a second foam fragment comprising a second porosity, wherein said second porosity is different than said first porosity.

5. The staple cartridge of claim 1, wherein said plurality of foam fragments comprises:

a first foam fragment comprising a first geometry; and

a second foam fragment comprising a second geometry, wherein said second geometry is different than said first geometry.

6. The staple cartridge of claim 1, wherein said plurality of foam fragments comprises:

a first foam fragment comprising a first material; and

a second foam fragment comprising a second material, wherein said second material is different than said first material.

7. The staple cartridge of claim 1, wherein said plurality of foam fragments comprises:

a first foam fragment comprising a first absorption rate; and

a second foam fragment comprising a second absorption rate, wherein said second absorption rate is different than said first absorption rate.

8. The staple cartridge of claim 1, wherein said implantable layer further comprises at least one medicament.

9. The staple cartridge of claim 1, wherein said implantable layer further comprises a plurality of fibers.

10. The staple cartridge of claim 1, wherein said plurality of foam fragments comprises:

a first foam fragment comprising a first medicament; and

a second foam fragment comprising a second medicament, wherein said second medicament is different than said first medicament.

11. A method of forming an implantable layer for use with a surgical stapler, the method comprising:

obtaining a plurality of foam fragments;

heating the foam fragments; and

compressing the foam fragments.

12. The method of claim 11, wherein obtaining the plurality of foam fragments comprises grinding at least one piece of foam to form the plurality of foam fragments.

13. The method of claim 11, further comprising sorting the plurality of foam fragments.

14. The method of claim 11, wherein heating the foam fragments comprises heating the foam fragments to a temperature above a glass transition temperature of the foam fragments and below a melting temperature of the foam fragments.

15. The method of claim 11, wherein heating the foam fragments and compressing the foam fragments occurs simultaneously.

16. The method of claim 11, wherein the plurality of foam fragments comprises:

a first foam fragment comprising a first medicament; and

a second foam fragment comprising a second medicament, wherein the second medicament is different than the first medicament.

17. The method of claim 11, further comprising:

obtaining at least one adjunct; and

combining the at least one adjunct with the foam fragments before heating the foam fragments and before compressing the foam fragments.

18. The method of claim 17, wherein the at least one adjunct is selected from a group consisting of an antibacterial adjunct, a fibrous adjunct, a collagen adjunct, and combinations thereof.

19. A method of forming an implantable layer for use with a surgical stapler, the method comprising:

obtaining a mold comprising a cavity;

generating bubbles within a solution;

dispensing the solution into the cavity of the mold; and

lyophilizing the solution in the cavity.

20. The method of claim 19, further comprising applying vibrations to the mold after dispensing the solution into the cavity.

21. The method of claim 19, wherein generating bubbles within the solution comprises whipping the solution.

22. A method of forming an implantable layer for use with a surgical stapler, the method comprising:

obtaining an insert mold comprising a first cavity;

forming a dissolvable insert in the first cavity of the insert mold;

removing the dissolvable insert from the first cavity;

obtaining a layer mold comprising a second cavity;

placing the dissolvable insert in the second cavity of the layer mold;

dispensing a solution into the second cavity around the dissolvable insert; and

lyophilizing the solution in the second cavity.